Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy

Overview

This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.

Full Title of Study: “Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 30, 2020

Detailed Description

Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.

Interventions

  • Drug: Dexamethasone injection
    • Group A consisted of patients given 5 mg intravenous dexamethasone after induction.
  • Drug: Haloperidol Injection
    • Group B consisted of patients given 1 mg intravenous haloperidol one hour before the surgery ended

Arms, Groups and Cohorts

  • Active Comparator: Dexamethasone
    • 5 mg intravenous dexamethasone
  • Active Comparator: Haloperidol
    • 1 mg intravenous haloperidol

Clinical Trial Outcome Measures

Primary Measures

  • Nausea and Vomiting
    • Time Frame: Within 24 hours postoperative
    • Number of patients experiencing nausea and vomiting postoperative

Secondary Measures

  • Pain and VAS
    • Time Frame: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
    • Visual Analog Scale (VAS) score, the minimum score is 0 and the maximum score is 10. The higher scores mean a worse outcome

Participating in This Clinical Trial

Inclusion Criteria

  • underwent laparoscopic surgery (gynecology, digestive, or urology surgery) – American Society of Anesthesiologist (ASA) physical status 1-3 Exclusion Criteria:

  • psychological or neurological disorders (routine haloperidol consumption) – history of allergic reaction to dexamethasone or haloperidol – diabetes mellitus – did not give the consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aldy Heriwardito, Principal Investigator – Indonesia University
  • Overall Official(s)
    • Aldy Heriwardito, Doctor, Principal Investigator, Indonesia University

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